Ep. 103 - Kolchinsky: FDA Conservatism, MFN and IRA Are Slowing Drug Development
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Ep. 103 - Kolchinsky: FDA Conservatism, MFN and IRA Are Slowing Drug Development
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Caution: This episode of The BioCentury Show contains strong language.
In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warns that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.
In conversation with BioCentury Washington Editor Steve Usdin, Kolchinsky also discusses U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and why he’s concerned that the biopharma sector is too “genteel” in its advocacy. Kolchinsky explains his decision to speak publicly about regulatory and political issues, including immigration, and reflected on China’s expanding role in the global life sciences innovation ecosystem.
View full story: https://www.biocentury.com/article/658433
#BiotechPolicy #FDALeadership #DrugPricingPolicy #LifeSciencesInnovation #CapitalMarkets
00:00 - Introduction
00:37 - Impact of FDA Policy Changes
06:17 - MFN & Drug Pricing in Europe
20:16 - The Importance of Speaking Up
34:26 - China & Innovation